Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis

NCT00004196 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000067439UAB-9735UAB-F970925009NCI-G99-1654RPCI-DS-99-14
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Interferon alfa-2b may interfere with the growth of cancer cells. PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis.

Conditions

Melanoma (Skin)

Keywords

stage I melanoma; stage II melanoma; stage III melanoma

Study Arms (5)

AI

EXPERIMENTAL

Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms. Patients receive adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks, then subcutaneously 3 times a week for 48 weeks

Biological: recombinant interferon alfa

Arm AII

EXPERIMENTAL

Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms. Observational arm: Patients with metastases in more than one sentinel node with evidence of extracapsular extension or metastasis in any nonsentinel node receive adjuvant high-dose interferon alfa-2b as in arm AI.

Biological: recombinant interferon alfa; Drug: Observation

Arm BI

EXPERIMENTAL

Patients with positive sentinel node(s) by PCR analysis are randomized to one of three treatment arms. Patients undergo observation. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Drug: Observation

Arm B II

EXPERIMENTAL

Patients with positive sentinel node(s) by PCR analysis are randomized to one of three treatment arms. Patients undergo lymph node dissection. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Procedure: lymphangiography

Arm BIII

EXPERIMENTAL

Patients with positive sentinel node(s) by PCR analysis are randomized to one of three treatment arms. Patients undergo lymph node dissection followed by adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Biological: recombinant interferon alfa; Procedure: lymphangiography

Interventions

recombinant interferon alfa BIOLOGICAL

AI; Arm AII; Arm BIII

lymphangiography PROCEDURE

Arm B II; Arm BIII

Observation DRUG

Arm AII; Arm BI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive cutaneous melanoma * Breslow thickness at least 1.0 mm * Primary site must be on head, neck, trunk or extremity * No more than 90 days since biopsy * Protocol A: * One or more sentinel lymph nodes with histologic or immunohistochemical evidence of metastatic melanoma * Prior regional lymph node dissection * Protocol B: * Sentinel lymph nodes with no histologic or immunohistochemical evidence of metastatic melanoma * Sentinel lymph node positive by reverse transcriptase polymerase chain reaction * No prior wide local excision of the primary tumor with a margin greater than 1.5 cm * No primary melanoma involving the eye or mucous membranes * No clinical evidence of satellite lesions or intransit, regional nodal, or distant metastases * No second primary invasive melanoma * No prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns (e.g., skin grafts, tissue transfers or flaps, or lymph node dissections) PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * Karnofsky 70-100% Life expectancy: * At least 10 years Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 70,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT/SGPT less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN * No severe decompensated liver disease (e.g., cirrhosis or autoimmune hepatitis) * No other significant liver disease that would preclude study participation Renal: * Creatinine normal Cardiovascular: * No cardiovascular disease (e.g., angina or congestive heart failure) * No myocardial infarction within the past year * No tachyarrhythmias Pulmonary: * No severe debilitating pulmonary disease (e.g., chronic obstructive pulmonary disease) Other: * No hypersensitivity to interferon alfa-2b or related compounds or any component of the injection * No major depression or other major psychiatric illness * No thyroid disorder with thyroid function that is not maintained within the normal range with medications * No autoimmune disease * No primary or secondary immunodeficiencies * No severe diabetes mellitus prone to ketoacidosis * No significant retinal abnormalities * No evidence of infection * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I laryngeal cancer * No other medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after the study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * At least 6 months since prior oral or parenteral steroids Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * No prior organ transplantation Other: * At least 6 months since prior immunosuppressants * No concurrent immunosuppressants resulting from prior organ transplantation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Interferon-alpha; Observation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Methods; Investigative Techniques

Study Officials

• Marshall M. Urist, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 1999
• Primary Completion: October 1, 2004
• Study Completion: November 1, 2007
• Last Updated: January 20, 2014

Record last verified: 2013-04

Locations

US (4)